AMLEarly Phase 1NCT05239689
Clinical Study of CD38 CAR-T Cells in the Treatment of Hematological Malignancies
A Early Phase 1 study testing CD38 CAR T-cells in people with AML, run by Zhejiang University at 1 site in China.
Trial summary
Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AML
- What is being tested?
- CD38 CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2022to 5 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients is histologically diagnosed with CD38-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021）;
- 2. The diagnosis is consistent with r/r CD38 + AML, and includes any of the following conditions:
- No CR was obtained after 2 courses of standard chemotherapy
- The first induction was CR, but the duration of CR was less than 12 months
- No CR was obtained after the first or multiple remedial treatment
- Relapse twice or more
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- 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry);
- 4. No active lung infection, inhaled air oxygen saturation ≥92%;
- 5. The estimated survival time is more than 3 months;
- 6. ECOG score was 0-2;
- 7. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Who cannot join
- 1. Patients with history of epilepsy or other central nervous system diseases;
- 2. Patients with prolonged QT or severe heart disease;
- 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- 4. The patients with uncontrolled active infection;
- 5. Active hepatitis B or hepatitis C virus infection;
- 6. Previous application of gene therapy;
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- 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- 8. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- 9. Those who suffer from other uncontrolled diseases are not suitable to join the study;
- 10. HIV infection;
- 11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, PhD, 86-13605714822, hehuangyu@126.com
Yongxian Hu, PhD, +8615957162012, huyongxian2000@aliyun.com
About this study
Official title: Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
Read the detailed description
The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. CD38 is highly expressed in myeloid leukemia, and it has been confirmed that the treatment of targeting CD38 has great potential in the treatment of CD38-positive hematological malignancies. The center intends to apply for a clinical trial of CD38 CAR-T cells to treat CD38-positive hematological malignancies on the basis of preliminary research.
- Conditions
- AML
- Being tested
- CD38 CAR T-cells
- Keywords
- AML, CD38 CAR T-cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD38 CAR T-cellsBiological
Drug: CD38 CAR T-cells Each subject receive CD38 CAR T-cells by intravenous infusion Other Name: CD38 CAR T-cells injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment of CD38-positive Hematological Malignancies | Experimental | Administration of CD38 CAR T-cells A dose levels of 2-8*10E6/kg are administrated for each subject. Receives: Biological: CD38 CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after CD38 CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: Up to 90 days after CD38 CAR T-cells infusion
Secondary outcomes (5)
Concentration of CAR-T cells
In peripheral blood and bone marrow
Measured: From admission to the end of the follow-up, up to 2 years
Disease control rate, DCR
The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
Measured: From Day 28 CD38 CAR-T infusion up to 2 years
Duration of remission, DOR
The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause
Measured: 24 months post CD38 CAR-T cells infusion
Progression-free survival, PFS
The time from cell reinfusion to the first assessment of disease progression or death from any cause
Measured: 24 months post CD38 CAR-Tcells infusion
Overall survival, OS
The time from the cell reinfusion to death due to any cause
Measured: From CD38 CAR-T infusion to death，up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start28 Feb 2022 (estimated)
- Primary completion5 Dec 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239689
- Sponsor's protocol ID
- CD38-001
- Status last verified
- Feb 2022
- First submitted
- 1 Dec 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05239689
- Acronym / sponsor ID
- CD38-001
- Conditions
- AML
- Keywords
- AML, CD38 CAR T-cell therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
Detailed description
The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. CD38 is highly expressed in myeloid leukemia, and it has been confirmed that the treatment of targeting CD38 has great potential in the treatment of CD38-positive hematological malignancies. The center intends to apply for a clinical trial of CD38 CAR-T cells to treat CD38-positive hematological malignancies on the basis of preliminary research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of CD38-positive Hematological Malignancies | Experimental | Biological: CD38 CAR T-cellsAdministration of CD38 CAR T-cells A dose levels of 2-8*10E6/kg are administrated for each subject. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Patients is histologically diagnosed with CD38-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021）;
- 2. The diagnosis is consistent with r/r CD38 + AML, and includes any of the following conditions:
- 3. The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry);
- 4. No active lung infection, inhaled air oxygen saturation ≥92%;
- 5. The estimated survival time is more than 3 months;
Key exclusion criteria (11 listed)
- 1. Patients with history of epilepsy or other central nervous system diseases;
- 2. Patients with prolonged QT or severe heart disease;
- 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
- 4. The patients with uncontrolled active infection;
- 5. Active hepatitis B or hepatitis C virus infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD38 CAR T-cellsDrug: CD38 CAR T-cells Each subject receive CD38 CAR T-cells by intravenous infusion Other Name: CD38 CAR T-cells injection | Biological | Treatment of CD38-positive Hematological Malignancies |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days after CD38 CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 90 days after CD38 CAR T-cells infusion
Incidence of treatment-emergent adverse events [Safety and Tolerability]
5 secondary outcomes
Concentration of CAR-T cells
Time frame: From admission to the end of the follow-up, up to 2 years
Disease control rate, DCR
Time frame: From Day 28 CD38 CAR-T infusion up to 2 years
Duration of remission, DOR
Time frame: 24 months post CD38 CAR-T cells infusion
Progression-free survival, PFS
Time frame: 24 months post CD38 CAR-Tcells infusion
Overall survival, OS
Time frame: From CD38 CAR-T infusion to death，up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang, PhD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD38 CAR T-cells in people with AML, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days after CD38 CAR T-cells infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.